Quality Engineer, Finished Goods (Remote)
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Job Location:
Monthly Salary:
Posted on:
2 days ago
Vacancies:
1 Vacancy
Job Summary
What you will do
In this role you will act as the key Quality Assurance partner for Finished Goods Operations (FGO) supporting lot review product release and quality processes to ensure compliance with regulatory requirements. You will work closely with cross-functional teams including Microbiology and Operations to maintain consistency in acceptance and inspection activities in a highly regulated environment.
Main responsabilities:
- Perform lot review and product release activities for Finished Goods ensuring compliance with internal procedures and regulatory requirements.
- Review and approve quality documentation related to Finished Goods acceptance inspection and release processes.
- Coordinate with cross-functional teams (Operations Microbiology Regulatory) to ensure consistent execution of Finished Goods quality processes.
- Support nonconformance investigations and CAPA activities related to Finished Goods acceptance and inspection activities.
- Provide Quality Assurance support to resolve internal customer and supplier-related issues impacting Finished Goods compliance.
- Monitor and support quality metrics related to Finished Goods including nonconformances CAPA product holds and process changes.
- Support internal and external audits (e.g. FDA and other regulatory bodies) related to Finished Goods Operations.
- Drive continuous improvement initiatives to enhance Finished Goods acceptance inspection and release processes.
What you need
Required:
- Bachelors degree in Engineering.
- Minimum 2 years of experience as Quality Engineer within highly regulated environments (e.g. medical devices pharmaceuticals automotive aerospace).
- Experience reviewing documentation and supporting quality or operational processes.
- Knowledge of regulated environments and quality systems (e.g. GMP or equivalent).
- Fluent English proficiency (written and verbal).
- Proficiency in Microsoft Office (Excel Word PowerPoint).
Preferred:
- Experience with lot review product release or quality documentation processes.
- Familiarity with ERP systems such as SAP Oracle or similar.
- Experience supporting audits or quality system activities.
Required Experience:
IC
Key Skills
About Company
Stryker is a global leader in medical technologies and, together with its customers, is driven to make healthcare better. The company offers innovative products and services in MedSurg, Neurotechnology, Orthopaedics and Spine that help improve patient and healthcare outcomes. Alongsid ... View more
